# K972558: Bipolar Scissors

- Pathway: 510(k) (Traditional)
- Applicant: Enable Medical Corp.
- Decided: Oct 7, 1997 after 90 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945975 (1994). 5 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951387: Symbiosis Bipolar Scissors, Symbiosis Corp. (1995) Summary page 1.
- K945975: Evershears (R) Scissors, Bilap (R) Probes, Bicoag (R) Forceps, Everest Medical Corp. (1994) Summary page 1.
- K955001: Evershears Scissors, Bilap Probes, Bicoag Forceps, Everest Medical Corp. (1995) Summary page 1.
- K963930: CTS Midcab/SVH Bipolar Scissors, Cardiothoracic Systems, Inc. (1997) Summary page 1.
- K960476: Ethicon Bipolar Scissors and Accessory Cable, ETHICON, Inc. (1996) Summary page 1.

## Most influential descendants
- K981219: Oscar Bipolar Scissors and Oscar Bipolar Reusable Cartridges (1998), 8 descendants of its own
- K992996: Enable Endoscopic Bipolar Scissors (1999), 7 descendants of its own
- K001330: Sovereign Bipolar Instruments (2000), 6 descendants of its own
- K042077: Bitech Bipolar Scissors (2004), 4 descendants of its own
- K030890: Switchblade (2003), 3 descendants of its own

## Indications for use
The ENABLE Bipolar Scissors with ENABLE Bipolar Disposable Cartridges is intended to cut tissue and control bleeding through coagulation during general surgery.

Source page: https://510kreport.com/device/K972558
Methodology: https://510kreport.com/methodology